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A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02196038
Recruitment Status : Active, not recruiting
First Posted : July 21, 2014
Last Update Posted : September 10, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE July 15, 2014
First Posted Date  ICMJE July 21, 2014
Last Update Posted Date September 10, 2020
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2014)
Change in Short Physical Performance Battery (SPPB) [ Time Frame: Baseline and 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2014)
All-Cause rehospitalization [ Time Frame: 6 months from index hospital discharge ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 17, 2014)
Economic Analysis [ Time Frame: 6-months ]
Assess the economic impact of the intervention by comparing medical costs between treatment arms, inclusive of the cost for rehabilitation therapy, relative to its associated changes in health outcomes.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients
Official Title  ICMJE REHAB-HF: A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients
Brief Summary REHAB-HF: A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients, is a multicenter, randomized, attention-controlled, single-blind trial designed to examine the hypothesis that, in addition to standard care, a novel, tailored, progressive, multi-domain rehabilitation intervention administered to older patients with acute decompensated heart failure (ADHF) beginning early during hospitalization and continuing for 12 weeks will improve physical function and key clinical outcomes, including the rate of rehospitalization.
Detailed Description There will be three lead centers, Wake Forest Baptist Health along with Thomas Jefferson University and Hospital-Co-Investigator Dr. David Whellan, and Duke University Medical Center-Co-Investigator Dr. Christopher O'Connor. Each center may recruit up to 3 geographically close, tightly affiliated 'satellite' sites under their management and budgetary control. Together, these sites will recruit a total of 352 consenting patients ≥ 60 years old hospitalized with ADHF. Following informed consent and baseline testing, the participants will be randomized in a 1:1 fashion to receive a 12-week novel, progressive, multi-domain rehabilitation and exercise training intervention or attention control. The multi-domain rehabilitation intervention will include endurance, mobility, strength, and balance training and will be tailored based on participant performance in each of these domains. It will begin upon randomization during the hospitalization and will continue 3 times per week in an outpatient setting. Participants randomized to the attention control arm will receive all services ordered by their primary physician and will be contacted bi-weekly by study staff. All participants will undergo measures of physical function and quality of life at baseline, 1 month, and 3 months. Clinical events will be monitored for 6 months following the index hospitalization.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Decompensated Heart Failure
Intervention  ICMJE
  • Behavioral: multi-domain rehabilitation intervention
    Individual, tailored, progressive physical function rehabilitation intervention
  • Behavioral: Attention Control
    Usual care with bi-weekly contact from study staff
Study Arms  ICMJE
  • Attention Control
    Usual care group with bi-weekly contact from study staff
    Intervention: Behavioral: Attention Control
  • Active Comparator: multi-domain rehabilitation intervention
    Individual, tailored, progressive, physical function rehabilitation intervention
    Intervention: Behavioral: multi-domain rehabilitation intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 4, 2019)
352
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2014)
360
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 60 years old
  • In the hospital setting >24 hours for the management of ADHF, or diagnosed with ADHF after being hospitalized for another reason. ADHF will be confirmed by the study physician, and will be defined according to the Food and Drug Administration definition of hospitalized heart failure as a combination of symptoms, signs, and HF-specific medical treatments.

Exclusion Criteria:

  • Acute myocardial infarction
  • Planned discharge other than to home or a facility where the participant will live independently
  • Already actively participating in formal, facility-based cardiac rehabilitation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02196038
Other Study ID Numbers  ICMJE IRB00028221
R01AG045551 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Dalane W. Kitzman, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP